Adjustable Dosing to Optimize Anemia Management:
A Case Study Analysis
Objectives of the meeting
Objectives of our meeting today...
Usage of CQI initiative in a dialysis facility
...are to examine how a dialysis facility used a CQI initiative to develop and implement an IV iron protocol. We are also going to assess the impact of our new IV iron protocol within our unit and I am just going to be talking about our unit and how we developed a protocol.
What is a CQI initiative?
First of all, what is a CQI initiative? It is a philosophy of management that requires members of a team to regularly monitor patient data and trends and to evaluate and update processes to produce better outcomes. Some of the key strategies are to organize a team, benchmark your current processes, see where you are at, identify opportunities for improvement, implement a plan, evaluate the results, and to revise the plan as necessary. And I know all of you went to nursing school and remember the nursing process and it is the exact same thing. In a nurse-driven CQI process, the nurse manages the activities and movements of the CQI initiative and we have involved the physicians in progress updates and in approval of changes.
Benefits of a CQI initiative
There are several benefits of a CQI initiative. One benefit is improved outcomes. A program allows you to look at your poor responders, see whether or not they are responding. It may include, you need to switch your IV iron to look at patient labs differently. Another benefit is increased patient satisfaction. As patients reach their target hemoglobin, they are going to be feeling better, they are going to be in the hospital less, they are going to have more energy, and these improvements in patient well being will result in enhanced patient satisfaction with the overall hemodialysis experience and more confidence in the healthcare team. Another benefit is enhanced safety. A CQI program can prevent deviations from standard practices in dosing the iron and the Epogen and in a busy dialysis unit, there is always that chance of a mistake, so the fewer times that you are changing a dose, the less chance of error.
CQI Process in action
In the spring of 2004, the Kidney Institute of Wisconsin started a CQI initiative. We are currently an outpatient dialysis unit with 28 stations. At the time we started this study, we had about 75 patients and now we have around 160 patients. We have 6 physicians, 10 nurses, 23 technicians, 2 dietitians and social workers, and a pharmacist.
Formation of the team
When we formed this team, we mainly used only 1 physician. Each physician in our group has kind of an area of expertise. One does PTH, one does infection, and one does the anemia. We purposely only used 1 physician, because as you know if you would get more than 1 physician in a room, each one is going to have a little bit different idea and it is just harder to get the ball rolling.
Opportunities for improvement
Opportunities for improvement - the majority of our patients were experiencing high ferritin levels. Most of our patients had ferritin levels over 800, so we wanted to look at the reason for that. Using that process, we looked at our current IV iron environment and found opportunities for improvement. We consulted various personnel, reviewed current literature, and then we decided to switch from iron sucrose, which we were using to sodium ferric gluconate. Because we were changing interventions, we decided it was very important to educate the staff. We had people from the iron company come and give in-services to the staff, which includes the nurses, techs, dietitians, social workers. Those people were also part of the team and they each brought a little bit different perspective of anemia to the group.
Our preliminary goals were to decrease the percentage of patients with serum ferritin greater than 800. Also to increase and maintain the number of patients who had hemoglobins greater than 11. We also wanted to improve the balance of EPO and iron therapy, and we wanted to simplify or at least not complicate the process that we currently have.
Developing an IV iron protocol
Step 4, we developed a plan of intervention. After deciding to implement a protocol using ferric gluconate, we decided we needed to look at optimal dosing parameters, and in deciding how much you should be giving the patients, it is important to consider what Andrea had said, that patients do lose between 1 and 3 g of iron annually. They also have ongoing blood loss due to drawing labs, cells left in the dialysis system, clotted dialyzers, GI bleeds, surgery, access problems. Therefore, if you are using maintenance iron dosing, if you give 62.5 mg per week, they will get roughly 1.6 g of iron per year or if you use 125 mg of iron per week, they would be receiving around 3 g per year.
Ferric gluconate as a practical dosing option
Ferric gluconate is available as a 62.5-mg ampule of iron and it offers a practical dosing option for therapy. You can give the entire amp at one time rather than giving part of it and throwing it away and you know how nurses hate to waste anything, so it is important to us that we could use the entire vial and did not have to waste anything.
Effective IV iron protocol
This slide just shows our basic iron protocol. This is also on the website that I mentioned before. The first section includes repletion and that is the iron that you give as a bolus, 125 mg x8 doses, which equals 1 g. Iron depletion is considered a TSAT of less than 20 and a ferritin of less than 100. The bottom part of the slide is how we do maintenance dosing, and these are only in patients with hemoglobins that are already over 11.
General assessment guidelines
For general assessment of those patients who do not achieve a hemoglobin over 11, we have a couple of different tools that we use. The first tool is interventional supplementation, and it is used by the anemia manager in patients who are not achieving hemoglobin of 11 despite IV iron and EPO therapy. It gives examples of lab values and different interventions that you can use and all of these examples are K/DOQI recommended and research based. We also have a triage supplement that we use for those patients who have multiple conditions or multiple complications and what that really is just your thought process on a piece of paper that lists all the different things that you should be looking at to see why a patient is not responding to EPO or to iron.
Implementing the plan
Step 5 - to implement the plan. After we evaluated the literature, we decided to go ahead with the IV iron protocol. In our unit, we give iron on lab draw days, so we draw our labs at the beginning of the run. They get their IV iron dose that day, so the labs that you are getting are not affected by giving IV iron. With sodium ferric gluconate, you do not really need to wait 48 hours to get an accurate result but because when we used iron dextran in the past, that always affected that. So, we just kept it the same to keep it simple for the staff.
Outcomes after the implementation protocol
This graph shows our outcomes after the implementation protocol. In March 2004, average ferritin level was 1044. In December 2004, after switching to ferric gluconate, our average ferritin was 624.
Different serum ferritin levels
This slide shows the percentage of patients with serum ferritin greater than 800. In March, we read a high of 64% and it dropped down to 29% in December. More importantly, this slide shows that we had administered more IV iron to more patients and our average serum ferritin levels still remained under 800. All of these improvements occurred despite an increase in census of 116 patients to 145 patients. The improvement is possible even with new patients who have not been on iron or EPO predialysis. The important point is to start IV iron right away upon admission. We generally get labs from the physician's office or from the hospital of the new patients before they start, so on their first treatment, they may be started on IV iron right away. The only time that you will look at numbers singly like that 1 hemoglobin, 1 ferritin, and 1 TSAT is on a brand new patient. After that, every time you look at numbers, you are looking at trends, you are looking at trends in the hemoglobin, the iron, and their medication dosing.
Serum ferritin levels on ferric gluconate
Several reasons that we felt why our serum ferritin levels have improved. In a 2002 study by Zager and Agarwal, they felt that ferric gluconate caused a small inflammatory response leading to reduced ferritin level. Also giving ferric gluconate 62.5 mg per week or every other week offered better control of serum ferritin levels than us giving iron sucrose, and we were giving 50 to 100 mg per week.
Impact of IV iron protocol on hemoglobin
This slide just shows the percentage of patients who were over hemoglobin of 11 in May 2004. We had 76% of our patients with hemoglobin over 11 and by the end of our study in December, it rose to 86%.
Hemoglobin levels on ferric gluconate
We felt that the improved hemoglobin response was due to use of ferric gluconate, the steady increase in the percentage of patients receiving IV iron, and the unit's consistent adherence to the new iron protocol. We also suggested that the increase in patients achieving target hemoglobin levels could be attributed to the more aggressive treatment of inflammatory processes. Andrea did cover that. Depending on TSAT and ferritin, we will give someone 1 g of iron to see if they have functional iron deficiency and see if the hemoglobin does improve with that.
IV Iron and EPO balance
This slide shows our balance. When we first started out, only 33% of our patients were receiving IV iron because the iron was being held, because their ferritin level was so high. In September, we reached a high EPO dose of 83,000 units on average. Once we hit that peak, then we balanced off in December of that year. 67% of our patients were on IV iron and our average EPO dose dropped from 85,000 to 66,000.
New protocol in management of anemia
Finally, our feedback showed the new protocol is not more complicated than the previous process that we had. In fact, it made the iron management process a lot easier for us considering that during this period, our patient population did increase by 34% and the percentage of patients with hemoglobin levels greater than 11 did increase by 10% and also to reiterate back to what I had said - at this point, you are always looking at trends, you are never looking at 1 number alone.
Note used for charting
This next slide will show, this is a note that we use for charting. The note report. It is a template. You could fill in the blanks. Patient name, type of note, the date, description of what the note, is anemia, who the person is, we always list our target hemoglobin level, whatever the EPO dose is that has changed, the rationale for changing it. If you change your iron dose, you could list that, and then there is a place to put the suspected cause of low hemoglobin. This information is very important to justify your EPO and iron dosing and to get correct reimbursement. This information is probably going to change on our notes along with once the new K/DOQI anemia guidelines come out. They are going to be released this spring at the NKF Spring Clinical in Chicago and it is going to be very important that you show 25% decrease in EPO dosing if the patient's hemoglobin gets over 13. If you choose not to decrease your dosing by 25%, Medicare will choose to pay you 25% less.
This slide just shows a report. We have a computer system and we can put in a date range and it will show us all the information that we need to look at, at one time. It lists the hemoglobin, TSAT, ferritin, and all the different medications. After Andrea's presentation, I was writing down additions so we are going to put URR, TIBC, and PTH level on there. Then in one picture, you can see if someone is not meeting it, it is going to have all your lab values that you could look at all at one time. This is a 3-month range. It has your hemoglobin, it has your TSAT and ferritin, and then you could look to see how the iron and EPO doses have changed over time. This reports allows the anemia manager to follow a consistent train of thought and it also makes it easier for another nurse to come in. She can look back at the last note, kind of see the trends, what the person before her did, and then do a very similar change. In the past, we had 2 anemia managers because we have 160 patients, so it does take a lot of time but the two of them decided it was easier for one person just to do it and then the other person is the backup. You might decide within your unit, it is easier to have each nurse or have just a couple of nurses to do it. I think it is easier to have fewer people doing it, to have one or two people doing it, then that thought process is consistent and the consistency stays the same.
Final step of the process
The final step of the process is to revise the plan as necessary. We concluded our goals were achieved. We did get patients' ferritins down under 800 but the CQI process requires that you are always looking at the trends and always maintaining, trying to keep your trend and to improve it. In order to do this, you need to always keep reviewing your processes and make decisions as needed.
Proactive iron dosing
For proactive iron dosing, our goals.
Goals for 2005
After 2004, goals for 2005 - we found we had quite a few patients, once they started getting iron routinely, their hemoglobin would be 11 and all of a sudden it would be up to 14. Now, especially with the new guidelines, the new reimbursement, we are looking at ways to cut back the EPO and/or the iron dose a lot sooner before they soar up into that high range. Someone going from 11 to 12.3, which is in range within 1 month, we would start cutting the dose back already because in the next month, they are going to be 13.5 or 14. We are also looking at estimating the iron needs of patients, especially new patients to go from 8 to 11 just giving them enough iron for that process plus giving them enough iron to offset the losses that they have during dialysis. This just reiterates iron replacement in an average dialysis patient. Stable patients stabilize between 1 and 2 g of iron per year. They use roughly 15 to 25 mL of whole blood per treatment session and that is without any adverse events, their needles falling out, dialyzer clotting, whatever. At a hemoglobin of 11.7 or hematocrit of 35%, 3 mL of blood equals 1 mg of iron and to just show, 1 mg of iron is lost each day through the GI tract. In order to estimate their iron needs, you need to remember all the iron losses that can occur in a dialysis patient.
Estimated annual iron losses
This is a slide that Andrea showed also. It just gives you an idea, a picture of you of how much iron and why the patients lose iron. There is normal iron losses, blood retained in the dialyzer, accidental losses, needle falls out, clotted dialyzer. Some people have a lot of lab tests drawn, for PTH, for pro times, hemoglobins. There are always some tests they want, a PSA, and so they do have a lot of blood draws done monthly also.
Maintenance therapy meets the patient's ongoing iron needs. A continuous source of iron is needed to optimize the body's supply of iron so you can continually make red blood cells. You need to look at the patient's needs, what they need, and to make sure you give enough iron to bring them up if they are below 11, to give enough iron to go from 8 or 9 up to 11. By adhering to a maintenance treatment, by giving so much every week or every other week rather than loading, giving them 1 g, stopping, waiting to see what happens, giving them another gram, it is much easier to give a continual low dose of iron. Loading and holding also involves having to write orders to start the drug, stop the drug, do it over and over, and with the small weekly dose of iron, this extra task of writing those orders is eliminated.
In conclusion, an effective adjustable dosing protocol can optimize anemia management. You can stabilize your hemoglobin values and improve patient outcome, improve the balance of EPO and iron dosing, which is very important, decrease wastage of drug and potential medication errors, and remind the anemia managers and clinicians that patient-specific interventions are still needed. Each patient needs to be looked at as an individual and by utilizing the different assessment tools, it will take you through the process of what you need to look at to see where the patient is at. You also need to remember that you continually have to look at your numbers. If all of a sudden, for the last 2 years, 84% of your patients have had a hemoglobin greater than 11, what about the other 16% who are out there. You have to keep looking at the reasons and the reasons can change. We were looking at ferritins 2 years ago and now we are looking at how much IV iron we give, how much iron they use, and trying not to overshoot the top of the goal. You have to keep looking at your outcomes, you might still have the same percentage of patients in that range, but the reasons for that are going to be changing. You need to constantly look at that and that is the true definition of CQI.
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